(56 days)
Ultrapak E
Not Found
No
The summary describes a physical retraction cord with a chemical impregnation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for temporary retraction and haemostasis of the gingival margin, which are therapeutic actions.
No
The device is described as a retraction cord for temporary retraction and hemostasis of the gingival margin, which are treatment-oriented functions, not diagnostic ones.
No
The device description explicitly states it is a "retraction cord with a metal core," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary retraction and haemostasis of the gingival margin." This is a direct application to the patient's tissue (gingival margin) for a physical effect (retraction and stopping bleeding).
- Device Description: The description confirms it's a "retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate." This is a physical device used in a clinical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (on the body) for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
Product codes (comma separated list FDA assigned to the subject device)
MVL
Device Description
Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ultrapak E
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Submission Stay-put impregnated 510(k) Summary
JUN 1 5 2004
Image /page/0/Picture/2 description: The image shows the logo for "coltène whaledent". The word "coltène" is in lowercase letters and is stacked on top of the word "whaledent", which is also in lowercase letters. There are three diagonal lines to the right of the word "coltène". The logo is in black and white.
This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR § 807.92.
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The submitter of this premarket notification is: Coltène/Whaledent Inc. Henry Vogelstein 235 Ascot Parkway Cuyahoga Falls, OH 44223-3701 USA Tel.: (212) 289-4748 Fax: (212) 289-4748 This summary was prepared on February 20, 2004
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The name of this device is Stay-put impregnated. Its common name is Stay-put impregnated and its classification is retraction cord.
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Stay-put impregnated is substantially equivalent to Ultrapak E manufactured by Ultradent Products Inc.
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Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.
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The technical characteristics are similar to those found with the predicate device Ultrapak E. Both products are impregnated retraction cords for dental use. Differences are only in the compression aid.
H. Hogelster 4/19/04
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Coltene/Whaledent Incorporated C/O Mr. Henry J. Vogelstein Official Correspondent Designated U.S. Agent 1349 Lexington Avenue New York, New York 10128
Re: K041023
Trade/Device Name: Stay-Put Impregnated Regulation Number: N/A Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Codes: MVL Dated: April 19, 2004 Received: April 20, 2004
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your contentially equivalent (for the indications for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass succed in also encreat date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic nave been rochassiriou in approval of a premarket approval application (PMA). You may, Act (Tec) market the device, subject to the general controls provisions of the Act. The general thereore, mancer me act include requirements for annual registration, listing of devices, good controle pro reserved labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sam adations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Mr. Henry J. Vogelstein
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Anthony 20. nater for
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/1 description: The image shows the logo for "coltène whaledent". The word "coltène" is in lowercase letters and is stacked on top of the word "whaledent", which is also in lowercase letters. There are three diagonal lines to the right of the word "coltène".
Indications for Use
KO41023 510(k) Number (if known):
Device Name:
Stay-put impregnated
Indications for Use:
Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaper
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number: K6411023